Momo Reno Advance - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspnasal dosing spray

Composition:

1 dose of spray contains:

Active substances:

Azelastine hydrochloride - 140 mcg, Mometasone furoate - 50 mcg.

Excipients:

Avicel RC-591 [microcrystalline cellulose, carmellose sodium] - 0.910 mg, carmellose sodium -0.021 mg, dextrose-3,500 mg, polysorbate-80-0.0175 mg. Benzalkonium chloride 0.014 mg, disodium edetate 0.035 mg, neotame 0.0007 mg, citric acid monohydrate 0.0105 mg, sodium citrate 0.021 mg, water for injection up to 70 mg.

Description:

White or almost white suspension.

Pharmacotherapeutic group:Antiallergic agent - H1-histamine receptor blocker + glucocorticosteroid for topical application

ATX: & nbsp

Decongestants and other topical preparations

Pharmacodynamics:

Azelastine, a derivative of phthalazinone, is an antiallergic, long-acting agent. Azelastine is a selective H₁-gistaminoblocker, has antihistamine, antiallergic and membrane-stabilizing effect, reduces capillary permeability and exudation, stabilizes the membranes of mast cells and prevents the release of biologically active substances (histamine, serotonin, leukotrienes, a factor activating platelets, etc.)causing bronchospasm and contributing to the development of early and late stage of allergic reactions and inflammation.

Mometasone is a synthetic glucocorticosteroid (GCS) for topical application. Has anti-inflammatory and antiallergic effect when used in doses, in which no systemic effects occur. It inhibits the release of inflammatory mediators. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, which causes a decrease in the release of arachidonic acid and, accordingly, inhibition of the synthesis of metabolic products of arachidonic acid-cyclic endoperoxides, prostaglandins. It prevents the accumulation of neutrophils, which reduces inflammatory exudate and production of lymphokines, inhibits the migration of macrophages, leads to a decrease in the processes of infiltration and granulation. Reduces inflammation by reducing the formation of the chemotaxis substance (effect on the "late" allergy reaction), inhibits the development of an allergic reaction of immediate type (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells).

Pharmacokinetics:

Azelastine hydrochloride. Bioavailability after intranasal application is about 40%. The maximum concentration (Cmah) in the blood plasma after intranasal use is achieved in 2-3 hours. When administered intranasally in a daily dose 0,56 mg azelastine hydrochloride The average equilibrium concentration of azelastine hydrochloride in the plasma 2 hours after admission is 0.65 ng / ml. Doubling the total daily dose to 1.12 mg results in a steady average plasma azelastine concentration of 1.09 ng / ml. However, despite the relatively high absorption in patients, systemic exposure after intranasal administration is approximately 8 times lower than after oral administration of a daily dose of 4.4 mg of azelastine hydrochloride, which is a therapeutic oral dose for the treatment of allergic rhinitis. Intranasal use in patients with allergic rhinitis causes an increase in the level of azelastine in blood plasma compared with healthy subjects. Other pharmacokinetic data were studied when administered orally. Communication with blood proteins 80 - 90%. Metabolised in the liver by oxidation with the participation of the cytochrome P450 system with the formation of the active metabolite desmethylazelastine.It is excreted mainly by the kidneys in the form of inactive metabolites. The half-life (T1 / 2) of azelastine is about 20 hours, its active metabolite desmethylazelastine is about 45 hours.

Mometasone furoate. In intranasal application, the systemic bioavailability of mometasone furoate is <1% (with a sensitivity of 0.25 pg / ml). The suspension of mometasone is very poorly absorbed in the gastrointestinal tract, and then a small amount of mometasone suspension that can enter the gastrointestinal tract The pathway after nasal inhalation, before excretion with urine or bile is subject to active primary metabolism.

Indications:

Symptomatic treatment of seasonal and year-round allergic rhinitis.

Contraindications:

Hypersensitivity to any of the components of the drug.

Recent surgery or injury to the nose with damage to the mucous membrane of the nasal cavity - until the wound is healed (due to the slowing effect of GCS on the healing process).

- Children under 18 years.

Carefully:

Tuberculosis infection (active and latent) of the respiratory tract, untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with the defeat of the eyes (in the form of an exception, the prescription of the drug is possible with the listed infections as directed by the doctor), the presence of an untreated infection involving the nasal cavity in the mucosa process.

Pregnancy and lactation:

Appropriately planned and well-controlled studies of the drug in pregnant women were not conducted.

Azelastine hydrochloride is able to cause toxicity during fetal development in mice, rats and rabbits.

The use of the drug during pregnancy and during breastfeeding is contraindicated.

Dosing and Administration:

Intranasal. Inhalation of the suspension contained in the vial is carried out by means of a special dispensing nozzle on the vial.

For 1 dose of spray (azelastine hydrochloride -140 mcg / mometasone furoate - 50 mcg) in each nostril 2 times a day in the morning and in the evening.

Guide for using a vial with a dosing device

1. Remove the protective cap.

2. Before the first application of the nasal spray, it is necessary to "calibrate" it by pressing the dosing device about 6 times. If nasal spray is not used for 7 days or longer,it is necessary to re-calibrate by pressing the dosing device about 2 times, or by pressing the cover until there are splashes when pressed. It is necessary to place the index and middle fingers on the sides of the nasal adapter, and the thumb on the bottom of the bottle and, making a breath through the nose, press. Do not pierce the nasal adapter. Do not spray into eyes when spraying.

3. Clean the nostrils before use. Clamp one nostril, and, slightly tilting the head forward, insert the end portion of the nasal adapter into the other nostril, while holding the vial vertically. Quickly and abruptly push the adapter. Do not spray on the nasal septum.

4. Exhale through the mouth.

5. Repeat the steps described in step 3 for the other nostril.

6. Wipe the nasal adapter with a clean cloth and put on the protective cap.

Instructions for cleaning the nasal adapter

1. Remove the protective cap.

2. Carefully remove the nasal adapter by pulling it upwards.

3. Rinse the nasal adapter with cold running water from both sides and dry. Do not use any auxiliary items (such as needles or sharp objects) to clean the adapter to avoid damaging it.

4.Rinse the protective cap with cold running water and dry.

5. Install the nasal adapter to its original position. Make sure that the stem of the vial is placed in the center of the nasal adapter.

6. Calibrate by pressing the metering device 2 times, or by pressing the cover until a fine dispersion starts to stick out firmly when pressed. Do not spray into the eyes.

7. Put the protective cap on.

Patients with impaired renal function

In patients with impaired renal function of mild degree (creatinine clearance> 79 ml / min) dose adjustment is not required. Patients with impaired renal function moderate to severe (creatinine clearance of <79 mL / min to> 10 ml / min), the drug should be used with caution and under strict medical control.

Patients with impaired hepatic function

In patients with impaired liver function, dose adjustment is not required.

Side effects:

In general, the Momat Rino Advance drug is well tolerated. Side effects are usually mild and, as a rule, do not require withdrawal of the drug.

In a clinical study in 560 patients aged 12 to 65 with seasonal allergic rhinitis, 282 patients received azelastine hydrochloride + mometasone furoate (nasal spray) for an average of 14.94 days.

In general, the safety profile of the drug azelastine hydrochloride + mometasone furoate (nasal spray) was comparable to the profiles of individual components used in the form of monotherapy in the study, as well as consistent with the available published data on monotherapy by individual components of the combination. In total, 18 adverse events associated with the use of azelastine hydrochloride + mometasone furoate (nasal spray), in 11 of 282 patients. The most frequent The undesirable reactions recorded in the study were headache (5 cases) and dysgeusia (5 cases). Other undesirable reactions were drowsiness (3 cases), retardation (2 cases), nausea (1 case), dyspepsia (1 case), and sneezing (1 case). Most of these adverse events were mild in severity, no serious adverse events were reported during the study.

According to the data of the World Health Organization (WHO), undesirable effects are classified on the basis of system-organic classes according to their development frequency as follows:

very often ≥1 / 10;

often from ≥1 / 100 to <1/10;

infrequently from ≥1 / 1000 to <1/100;

rarely from ≥1 / 10000 to <1/1000;

rarely <1/10000, including individual messages;

the frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

Below are the undesirable drug reactions recorded with the use of individual components of the combination of fixed doses.

Azelastine hydrochloride

With the use of azelastine hydrochloride (nasal spray), recorded adverse reactions were observed at the following frequency:

Often: after application, a substance-specific bitter taste may be felt (often due to an incorrect application, namely, excessive tipping of the head back during insertion), which in rare cases can cause nausea.

Infrequently: light, transient irritation of the inflamed mucous membrane of the nasal cavity can occur with such symptoms as burning, itching, sneezing and nosebleeds.

Very rarely: Hypersensitivity reactions have been reported (such as rash, itching, urticaria), anaphylactoid reactions, dizziness, fatigue, drowsiness, weakness (may be caused by the disease itself).

Mometasone furoate

According to reports on clinical studies with allergic rhinitis, nosebleeds were usually self-stopping, mild and more frequent than with placebo (5%), but with similar frequency or less frequently than with the control nasal glucocorticosteroids (up to 15% ). The incidence of all other adverse events was comparable to that in placebo. In patients treated for nasal polyposis, the overall incidence of adverse events was similar to the frequency observed in patients with allergic rhinitis.

When Systemic effects may occur with the use of nasal glucocorticosteroids, especially with prolonged use of high doses of these drugs. Treatment-related adverse reactions (> 1%) recorded in clinical trials in patients with allergic rhinitis or nasal polyposis, as well as in the post-marketing period, regardless of the indication for use, are presented in the table.

Registered adverse reactions associated with treatment, according to system-organ classes and frequency

	Often	Often	Frequency unknown
Infections and invasions		Pharyngitis, Upper respiratory tract infection **
Disorders from the immune system systems			Hypersensitivity, including anaphylactic reactions, angioedema, bronchospasm and dyspnoea
Disturbances from the nervous system		Headache
Disturbances on the part of the organ of sight			Glaucoma Increased intraocular pressure Cataract
Disturbances from the respiratory system, chest and mediastinal organs	Nasal bleeding	Nose bleed Burning in the nose Irritation in the nose Ulceration in the nose	Perforation of the septum of the nose
Disorders from the gastrointestinal tract		Persecution in the throat * (Sensation of irritation of the mucous membrane of the pharynx)	Disorders of taste and smell

* registered with a dosing regimen twice a day with nasal polyposis therapy

** is infrequently recorded with the dosing regimen twice a day for nasal polyposis therapy

Pediatric patients In the pediatric population, the incidence of adverse events recorded in clinical studies, such as epistaxis (6%), headache (3%), nose irritation (2%), and sneezing (2%) was comparable to that of placebo.

Overdose:

At present, there are no known cases of drug overdose with intranasal application. In case of an overdose of azelastine as a result of accidental ingestion, there may be disturbances from the nervous system (drowsiness, confusion, tachycardia, hypotension). Therapy of these disorders is symptomatic. With long-term use of glucocorticosteroids in high doses, as well as with the simultaneous use of several GCS, oppression of the hypothalamic-pituitary-adrenal system is possible. Due to the low systemic bioavailability of the drug, it is unlikely that an accidental or intentional overdose will require the taking of any measures other than observation with a possible subsequent resumption of the drug at the recommended dose.

Interaction:

Special studies of the interaction of active substances of the combined preparation with fixed doses of azelastine hydrochloride and mometasone furoate were not carried out. In addition, since u azelastine, and mometasone metabolized by various receptors,for a given combination of fixed doses of interaction of active substances is not expected.

The data on the interaction of the active substances of the combined preparation are given below.

Azelastine hydrochloride

In the intranasal application of azelastine hydrochloride, there is no clinically significant interaction with other drugs.

Mometasone furoate

Combination therapy with loratadine was well tolerated by patients. At the same time, there was no evidence of any drug effect on the concentration of loratadine or its main metabolite in blood plasma. In these studies mometasone furoate in the blood plasma was not detected (with the sensitivity of the method of determining 50 pg / ml).

Special instructions:

The following are special instructions for the active substances of the combined preparation azelastine hydrochloride + mometasone furoate (nasal spray).

The drug Momat Reno Advance is recommended for use only in adults over 18 years of age.

Azelastine hydrochloride

There are no specific instructions for the use of azelastine hydrochloride in the form of a nasal spray.

Mometasone furoate

Immunosuppression

Mometasone furoate (nasal spray) should be used with caution or should not be used in patients with active tuberculosis infection of the respiratory tract or suspected of having it, as well as with untreated fungal, bacterial or systemic viral infections.

Patients treated with glucocorticosteroids have potentially reduced immune reactivity and should be warned about the increased risk of infection in case of contact with patients with certain infectious diseases (for example, chicken pox, measles) and the need for medical advice if such contact has occurred.

Local nasal action

After 12 months of therapy with mometasone furoate (nasal spray), no evidence of atrophy of the nasal mucosa was found in patients with chronic rhinitis; In addition, in the treatment of mometasone furoate, there was a tendency for the mucous membrane of the nasal cavity to return to a normal histological phenotype. Nevertheless, patients who use mometasone furoate (nasal spray) for several months and longer, should be periodically inspected for possible changes in the mucous membrane of the nasal cavity. In the case of the development of a localized fungal infection of the nasopharynx, it may be necessary to cancel the mometasone furoate (nasal spray) or the appropriate treatment. Indication for the abolition of mometasone furoate (nasal spray) may be a constantly present feeling of irritation of the nasopharynx.

Mometasone furoate (nasal spray) is not recommended if there is a perforation of the nasal septum.

In clinical trials, nasal bleeding occurred more often than with placebo. Nasal bleeding was usually self-stopping and mild in severity.

Systemic effects of glucocorticosteroids

When using nasal glucocorticosteroids, systemic effects may occur, especially with prolonged use of high doses of these drugs. Similar effects occur with a much lower probability than with the use of oral glucocorticosteroids, and may differ in individual patients and in the use of different glucocorticosteroids.Potential systemic effects may include Cushing's syndrome, development of cushingoid features, suppression of adrenal function, growth retardation in children and adolescents, cataracts, glaucoma and, much less often, a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggressiveness (especially in children).

Cases of increased intraocular pressure after using intranasal glucocorticosteroids are described.

During the transition from treatment with systemic glucocorticosteroids to treatment with mometasone furoate (nasal spray), in some patients, initial symptoms of systemic glucocorticosteroid withdrawal (eg, joint and / or muscle pain, fatigue and depression) may occur, despite a decrease in the severity of symptoms associated with with defeat of the nasal mucosa; such patients need to specifically convince in the advisability of continued treatment with mometasone furoate (nasal spray). The transition from systemic to local glucocorticosteroids can also reveal allergic diseases, such as allergic conjunctivitis and eczema already masked by glucocorticosteroid therapy of systemic action.

Therapy with doses exceeding the recommended ones can cause clinically significant suppression of adrenal function. Therefore, during periods of stress or planned surgical interventions, when it is obvious the need for doses exceeding the recommended ones, consideration should be given to the possibility of additional use of systemic glucocorticosteroids.

Nasal polyps

The safety and efficacy of mometasone furoate (nasal spray) has not been studied in the treatment of unilateral polyps, polyps in cystic fibrosis or polyps causing complete obstruction of nasal passages. The use of the drug in unilateral polyps, which are characterized by unusual or heterogeneous appearance, especially if they are accompanied by ulceration or bleeding, requires additional study.

Unnatural symptoms

Despite the fact that intranasal mometasone furoate (nasal spray) provides control of nasal symptoms in most patients, the combined use of appropriate complementary medicines may allow to weaken other symptoms, especially ophthalmic.

The Momat Reno Advance drug contains benzalkonium chloride, which can cause irritation of the mucous membrane of the nasal cavity and bronchospasm.

Effect on the ability to drive transp. cf. and fur:

In rare cases fatigue, fatigue, dizziness and weakness, which can be a consequence of the disease itself, can develop with the use of the nasal spray Momat Rino Advance. In such cases, you should avoid driving and working with complex machinery.

Form release / dosage:

Spray nasal dosed, 140 mcg + 50 mcg / dose.

Packaging:

150 doses per vial of HDPE, equipped with a dosing device and a nasal adapter with a protective cap. The bottle with instructions for use is placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of 15 to 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003328

Date of registration:23.11.2015 / 12.09.2016

Expiration Date:23.11.2020

The owner of the registration certificate:Glenmark Pharmaceuticals Co., Ltd.Glenmark Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp